This is a research study to find out if a drug called belantamab mafodotin in combination with dexamethasone, a steroid, can be safely and effectively given in the community setting. Belantamab mafodotin (BLENREP) was approved in the US in August 2020 under an FDA program called accelerated approval. In November 2022, belantamab mafodotin was removed from the market because a study to further confirm its activity in relapsed/refractory multiple myeloma did not deliver a supporting result. However, this confirmatory study demonstrated that some patients may still benefit from treatment with belantamab mafodotin, and that this benefit can be long lasting. Belantamab mafodotin is often given at large academic medical centers every 3 weeks. This study will assess whether it is possible to administer belantamab in the community setting every 6 weeks. It is unknown if administering belantamab every 6 weeks versus every 3 weeks will result in improved safety and/or reduced efficacy.

开始日期2026-05-01

申办/合作机构

Duke University

NCT07285239

/ Not yet recruiting临床3期IIT

Randomized Phase 3 Trial of Belantamab Mafodotin or Daratumumab in Combination With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma

Eligible participants with newly diagnosed myeloma who are not considered eligible for bone marrow transplant will be enrolled. Participants will be randomized to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
Belantamab mafodotin is a targeted cancer treatment that works against multiple myeloma cells. It combines a homing device (an antibody) with a powerful cell-killing drug (a toxin), delivering the toxin directly to cancer cells while largely sparing healthy cells.
Minimal residual disease (MRD) testing will be done on bone marrow samples obtained standardly during your treatment. MRD shows whether a very small number of cancer cells can still be detected after treatment, even if standard lab tests shows no signs of cancer.
The purpose of this study is to evaluate if belantamab mafodotin, bortezomib, lenalidomide and dexamethasone (BVRd) improves minimal residual disease (MRD) negative status and/or prolongs progression-free survival (PFS) compared with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) in participants with newly diagnosed multiple myeloma.

开始日期2026-05-01

申办/合作机构

GSK Plc

NCT07224672

/ Not yet recruiting临床2期

A Phase 2, Open-label, Single-arm, Proof-of-concept Study Evaluating the Efficacy and Safety of Belantamab Mafodotin Administered in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain Amyloidosis (ALANIS)

The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .

开始日期2026-03-11

申办/合作机构

GSK Plc

100 项与玛贝妥单抗相关的临床结果

登录后查看更多信息

100 项与玛贝妥单抗相关的转化医学

登录后查看更多信息

100 项与玛贝妥单抗相关的专利（医药）

登录后查看更多信息

273

项与玛贝妥单抗相关的文献（医药）

2026-03-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

Respiratory Disorders Associated with Antibody–Drug Conjugates: A Combined Analysis of the French and the WHO Pharmacovigilance Databases

Article

作者: Lafay‐Chebassier, Claire ; Jutant, Etienne‐Marie ; Freppel, Romane ; Bihan, Kévin ; Mahé, Julien ; Bourneau‐Martin, Delphine ; Allouchery, Marion ; Hlavaty, Alex ; Cholle, Clément ; Hennegrave, Florence ; Mirleau, Victor ; Bainaud, Matthieu

Antibody–drug conjugates are proving to be highly effective in oncology, yet their real‐world respiratory safety profile remains largely unknown. This study sought to characterize drug‐linked respiratory disorders and identify safety signals. We performed a descriptive analysis with expert review of respiratory adverse drug reactions related to antibody–drug conjugates from the French pharmacovigilance database. We also conducted disproportionality analyses for interstitial lung disease, pulmonary arterial hypertension, and pleural disorder using VigiBase®. Among the 71 patients included in the descriptive study, 56 (78.9%) were women, and the median age was 60 years. Most (71.8%) were treated for breast cancer. Fifty‐nine patients (83.1%) developed antibody–drug conjugate‐related interstitial lung disease, primarily after trastuzumab deruxtecan. Nine patients (12.7%) developed pulmonary arterial hypertension and three (4.2%) contracted pleural disorders, mainly after trastuzumab emtansine. The median time to onset varied by clinical feature, with 1 month for pleural disorder, 4 months for interstitial lung disease, and 45 months for pulmonary arterial hypertension. The disproportionality analysis showed a significant signal for interstitial lung disease with brentuximab vedotin, polatuzumab vedotin, trastuzumab emtansine, and trastuzumab deruxtecan. Only trastuzumab emtansine had a significant signal for pulmonary arterial hypertension. All antibody–drug conjugates, except belantamab mafodotin and enfortumab vedotin, were associated with a significant signal for pleural disorders. Our study highlights the risk of interstitial lung disease with these drugs in real‐world settings and identified pulmonary arterial hypertension and pleural disorders as additional safety signals. Further research is needed to confirm these findings in population‐based studies and to identify antibody–drug conjugates and patient‐related risk factors.

2026-01-01·Targeted Oncology

Antibody-Drug Conjugates, T-Cell Engager Bispecific Antibodies and Chimeric Antigen Receptor T Cells for Multiple Myeloma: What’s the Current Status?

Review

作者: Segers, Finn ; Delforge, Michel

The treatment of multiple myeloma has changed significantly in the last decade. Antibody-drug conjugates, T-cell immunotherapies including bispecific T-cell engaging antibodies and chimeric antigen receptor T-cell therapies, have shown remarkable results in pivotal clinical trials. This has resulted in European Medicines Agency and US Food and Drug Administration approval of agents targeting the B-cell maturation antigen: antibody-drug conjugate belantamab mafodotin (belantamab), bispecific T-cell engaging antibodies teclistamab, elranatamab and linvoseltamab, and chimeric antigen receptor T-cell products idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel). Talquetamab, a bispecific T-cell engaging antibody targeting G protein coupled receptor family C group 5 member D has also been approved by the European Medicines Agency and Food and Drug Administration. With increasing availability of these agents, knowledge on the efficacy and safety of these novel treatments will be essential for future multiple myeloma care. In this narrative review, we discuss the pivotal trials, current real-world evidence and recent insights in the mechanisms of resistance of antibody-drug conjugates, bispecific T-cell engaging antibodies and chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen and G protein coupled receptor family C group 5 member D for multiple myeloma.

2025-12-05·Hematology-American Society of Hematology Education Program

Endless possibilities and how to exploit them? What is the optimal treatment sequence?

Review

作者: Lentzsch, Suzanne ; Bhutani, Divaya ; Chakraborty, Rajshekhar

Abstract:

The therapeutic landscape of multiple myeloma has undergone a profound transformation with the incorporation of anti-CD38 monoclonal antibody (mAb)-based quadruplet regimens in the frontline setting and T-cell redirecting immunotherapies in the relapsed setting. In this article, we synthesize evidence from pivotal trials to guide treatment decisions and sequencing across the disease trajectory. For transplant-eligible, transplant-deferred, and fit transplant-ineligible patients who are younger than 80 years old, we use anti-CD38 mAb-, lenalidomide-, and bortezomib/carfilzomib-based quadruplets as an induction regimen. For early relapse (1-3 prior lines), chimeric antigen receptor T-cell therapies targeting B-cell maturation antigen (BCMA) have demonstrated superiority over standard regimens, with ciltacabtagene autoleucel (cilta-cel) being the most efficacious product currently, albeit with some unique toxicities such as parkinsomism. Belantamab mafadotin-based triplets have shown impressive efficacy in lenalidomide and anti-CD38 mAb-refractory patients, although ocular toxicity remains a concern. Anti-CD38 mAb and carfilzomib-based triplets remain an essential therapeutic option in patients not refractory to anti-CD38 mAb. In late relapse (≥4 prior lines), bispecific antibodies (BsAbs) targeting BCMA (teclistamab, elranatamab, and linvoseltamab) and GPRC5D (talquetamab) have demonstrated impressive single-agent activity with distinct toxicity profiles. Emerging evidence supports prioritizing chimeric antigen receptor T-cell therapy before BsAbs when clinically feasible, as sequential efficacy appears compromised in the reverse sequence. For patients with BCMA- and GPRC5D-refractory disease, FcRH5-targeting BsAb (cevostamab), BCL2 inhibitors for t(11;14)-positive disease, and novel trispecific antibodies (BCMAXCD38; BCMAXGPRC5D) offer promising options. Strategic sequencing trials represent a critical unmet need, with PFS (progression-free survival)-2 potentially serving as a valuable intermediate end point to guide clinical decision-making while waiting for mature survival data.

592

项与玛贝妥单抗相关的新闻（医药）

2026-03-11

·allsci.com

BMS upbeat on protein degrader mezigdomide after Phase III results in relapsed multiple myeloma

Bristol Myers Squibb (BMS; NYSE: BMY) announced positive interim results from the SUCCESSOR-2 study, a Phase III trial evaluating oral mezigdomide in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. The readout marks the first positive Phase III study for mezigdomide and the second for the company’s CELMoD program, a platform of next-generation cereblon-modulating protein degraders central to BMS’s hematology pipeline. SUCCESSOR-2 (NCT05552976) is a seamless Phase II/III, multicenter, randomized, open-label trial comparing mezigdomide plus carfilzomib and dexamethasone (MeziKd) against carfilzomib and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma previously exposed to anti-CD38 therapy and lenalidomide. The primary endpoint of the Phase III portion was progression-free survival. According to the company, MeziKd demonstrated a statistically significant and clinically meaningful improvement in PFS over Kd. Exact hazard ratios, median PFS values, and p-values were not disclosed in the topline release. Safety findings were consistent with the known profile of mezigdomide and the combination regimen, with no new signals reported. Key secondary endpoints — including overall survival, overall response rate, duration of response, MRD negativity, and health-related quality of life — will be reported at a future medical meeting. Patients continue to be followed for survival and safety. BMS stated that data will be shared with health authorities, with no specific NDA filing timeline disclosed. Cristian Massacesi, the company’s chief medical officer, said the results “reinforce the value of our CELMoD program and our targeted protein degradation platform” and “strengthen our confidence in bringing forward effective, accessible oral treatment options”. Mezigdomide is a cereblon E3 ligase modulator (CELMoD) designed to bind cereblon, a substrate receptor of the CRL4 E3 ubiquitin ligase complex, and redirect the complex to ubiquitinate and degrade the transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). These proteins play key roles in the growth and survival of malignant plasma cells in multiple myeloma. By promoting their degradation, CELMoD agents enhance anti-tumor immune activity and induce myeloma cell death. The mechanism builds on the established immunomodulatory drug (IMiD) class, which includes lenalidomide and pomalidomide, therapies that have become central components of current multiple myeloma treatment regimens. Multiple myeloma remains an incurable malignancy characterized by repeated cycles of response and relapse. While treatment options for relapsed or refractory multiple myeloma (RRMM) have expanded substantially in recent years — including bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates — patients who have progressed on anti-CD38 antibodies and lenalidomide often face limited therapeutic options. In this setting, orally administered agents that can be combined with existing backbone regimens remain an important area of clinical development. The competitive landscape in RRMM spans several therapeutic modalities. Key competing assets include: Bristol Myers Squibb’s iberdomide, another CELMoD agent currently being evaluated in Phase III trials in combination with daratumumab and dexamethasone in relapsed or refractory multiple myeloma. Johnson & Johnson’s talquetamab, a bispecific antibody targeting GPRC5D and CD3 that is being evaluated in Phase III trials for relapsed disease. Pfizer’s elranatamab, a BCMA×CD3 bispecific antibody that received US FDA approval for relapsed or refractory multiple myeloma and is undergoing further Phase III evaluation. Johnson & Johnson and Legend Biotech’s BCMA-directed CAR-T therapy ciltacabtagene autoleucel, which the US FDA approved for multiple myeloma and is being studied in additional Phase III trials across earlier treatment lines. GSK’s BCMA-targeted antibody-drug conjugate belantamab mafodotin, which is being evaluated in ongoing Phase III combination studies following earlier regulatory setbacks. Mezigdomide’s oral administration and compatibility with established backbone regimens such as carfilzomib plus dexamethasone could position it as a convenient treatment option in later-line settings. However, the therapy’s eventual role in the treatment sequence will depend on the magnitude and durability of clinical benefit observed in Phase III studies relative to existing immunotherapies and cell-based approaches. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

临床3期临床结果免疫疗法细胞疗法上市批准

2026-03-10

·网易号

从“连续10年TOP1”到缩减“6%”，研投王者“踩”刹车背后

过去十年，跨国药企的研发投入几乎都指向一个方向：在新药越来越难做，单个产品的开发成本越来越高，技术平台越来越复杂的背景下，研发预算顺理成章地一路攀升。但到了2025年，风向似乎变了。开始有人猛踩油门，有人主动收手；有人把钱继续砸向后期管线和前沿技术，有人则把预算从内部研发转向BD、并购和优化自身资产配置。全球药企研发投入TOP10中的6家公司，都出现了不同规模的研投金额下滑，而这一数字在2024年是3家，2023年仅2家，并且是微跌。仅仅三年过去，MNC围绕新药研发的投入为何出现如此大的变化？当超级重磅炸弹的专利悬崖逼近、美国药价政策压顶、GLP-1和ADC等超级赛道虹吸资本、Biotech成为新兴技术赛道的创新源头，跨国药企们在坚持什么？又在放弃什么？谁在“踩刹车”？先看研投规模收缩的“阵营”。默沙东、罗氏、强生、辉瑞、BMS、艾伯维，这些占据全球制药业半壁江山的TOP级药企，不约而同地在过去一年踩下了研发投入的刹车。2025年，默沙东以158亿美元、占营收24.3%的研发投入总额领跑各大MNC，但同比12%的降幅也让人难以忽视。对此默沙东给出的解释是“业务拓展活动费用减少”。换言之就是“用于收购外部管线的钱少了。”但更关键的是，默沙东内部研发也在被精简。2025年7月，默沙东宣布终止多个重要研发项目，包括通过19亿美元收购Pandion Therapeutics获得的IL-2突变蛋白MK-6194，以及与康方生物合作开发的CTLA-4抗体MK-1308。按照计划，到2027年底前，默沙东将削减30亿美元年度支出，节约的成本全部投向重点管线。对默沙东而言，当下乃至未来几年都需要长期回答的一个问题是：Keytruda之后，谁来接班？默沙东在2025年公布了18项III期阳性数据、启动21项新的III期临床，并在2026JPM大会上表示，约有80项III期研究，新增管线的增长动力对应的商业机会“超过2028年Keytruda预测销售额的两倍”。从近两年默沙东看似分散，却也清晰的动作来看：默沙东并没有把全部筹码继续押在其肿瘤基本盘上，而正试图把增长引擎从单一的肿瘤王者，发展到多领域、多机制的组合。早在2023年时，默沙东花108亿美元买下Prometheus，拿到TL1A抗体tulisokibart，并且已经推进该药在溃疡性结肠炎和克罗恩病中的两项III期研究，并把适应证拓展到更多免疫介导疾病。同时，默沙东在2025年7月以约100亿美元收购Verona Pharma，直接拿下COPD吸入药Ohtuvayre，补齐呼吸系统的版图，被外界普遍视为默沙东在Keytruda专利悬崖前的布局。心血管也是默沙东近两年重新加码的方向。索特西普是全球首个激活素信号通路抑制剂，2024年获FDA批准用于肺动脉高压，默沙东在2025财报表示，索特西普对业绩增长的贡献正在提升。作为曾经的“研发之王”，罗氏在2011-2020连续十年间位居全球药企研发榜首。过去一年，2025年罗氏砸下122亿瑞士法郎（约148亿美元），按固定汇率计算减少6%（130.42亿瑞士法郎）。罗氏在肿瘤免疫领域，拥有几乎算得上MNC中最深厚的积累。但过去几年，TIGIT抑制剂等多个重磅在研药物在III期临床接连失败，导致罗氏大量研发投入打了水漂。2025年Q4，罗氏一口气终止了7个临床研究项目，包括RG6120（VEGFA×ANGPT2双抗）治疗新生血管性年龄相关性黄斑变性的I期临床、RG6221（LTBR×FAP-α双抗）治疗实体瘤的I期临床、抗肿瘤药RG6561的实体瘤I期研究、OSMRβ单抗RG6536（vixarelimab）治疗特发性肺纤维化或系统性硬化症相关间质性肺病（IPF/SSc-ILD）的II期临床试验、RG7446（阿替利珠单抗）用于NSCLC围手术期治疗的III期临床、CD3/CD20双抗RG7828（莫妥珠单抗皮下制剂）获批用于三线治疗滤泡性淋巴瘤（FL）。虽然研投有所收缩，但过去一年，罗氏也有10种关键分子进入III期临床试验，12项后期临床试验取得积极成果。与此同时，罗氏产品管线中仍有66个新分子实体和共计107个项目。肿瘤仍是主要研发领域，同时其在心血管、肾脏、代谢和免疫学领域也进行了大量投资。剧降29%。艾伯维是榜单中研投收缩最剧烈的公司。自从其核心产品修美乐2023年专利到期后，昔日药王的年销售额从2022年的212.37亿美元骤降至2025年的45.4亿美元，并且还在持续下行区间中。“失去Humira后如何生存”也成了艾伯维过去数年一直在找的答案。过去一年，艾伯维的研发总投入虽然降幅较大，但动作频频。作为修美乐之后的自免双子星之一的Rinvoq，在2025年达成持续拓展适应证。艾伯维已向FDA和EMA提交了 Rinvoq 治疗非节段性白癜风的新适应症申请，若能顺利获批，Rinvoq 将成为首个治疗白癜风的全身性疗法。除了内部研发，艾伯维也通过外部合作和收购加速管线扩充。通过与多家生物制药公司的合作，其管线覆盖了从自免到实体瘤、从早期研发到后期临床。谁在“加油门”？如果说默沙东、罗氏、艾伯维们代表的是在“收缩中进攻”，那么礼来、阿斯利康、GSK则是在“确定性赛道里持续加码”。礼来在榜单里“独树一帜”。礼来2025年研发投入133.37亿美元，同比大增21%，是Top10公司里，唯一增幅超过20%的。过去一年，礼来不仅有替尔泊肽、米吉珠单抗、Inluriyo等关键进展，其在2025年财报中还明确表示2026年研发支出还将继续加速增长。礼来大举研发的逻辑很明确：GLP-1。替尔泊肽（Mounjaro和Zepbound）已经站上全球药王的位置。GLP-1作为一个万亿美元级别的赛道，礼来正站在赛道的最前沿。研发投入的指向性也很明确：开发口服GLP-1、探索多靶点组合、拓展心血管适应证、解决产能瓶颈。2026年，礼来表示，受正在进行和新启动的后期项目推动，研发支出将继续加速增长。预计将迎来多项监管获批，包括替尔泊肽获批治疗心血管结局、Orforglipron获批治疗肥胖等。增长位居次席的是GSK。2025年其研发投入98.58亿，较上年增长19%。近年来，GSK正在从“疫苗和呼吸老牌巨头”向更强创新管线公司转型，并进入兑现期。在产品进展方面，包括Penmenvy（脑膜炎球菌病）、Blujepa（单纯性尿路感染）、Nucala（COPD）、Blenrep（多发性骨髓瘤）、Exdensur（重度哮喘）等产品获批。同时，GSK还启动7个III期临床，涉及COPD、MASH、胃肠道间质瘤、广泛期小细胞肺癌等多个适应证。目前，GSK产品管线中有58个资产，其中包括17个III期临床阶段项目。2026年，GSK预期将有5项关键临床数据读出，并启动10项关键临床试验。阿斯利康2025年研发投入142.32亿美元，同比增长4%，占营收24%。过去一年，阿斯利康取得了16项III期阳性数据，后期管线连续两年维持在37款左右，拥有超100项III期临床试验，并且，预计2026年还将有20余项III期临床结果。在2030年营收800亿美元目标的指引之下，阿斯利康在2026JPM大会上明确将“下一代IO双抗+高价值ADC”列为创新增长支柱，通过“自主研发+生态合作”覆盖肿瘤、自免领域，成为支撑其2030年800亿美元营收目标的关键力量。研投逻辑变了研投费用增长代表着一家公司加大投入，但研发支出下降，并不一定意味着创新收缩。当前MNC收缩研发投入的逻辑也相对清晰，可以归结为三个方面：其一，核心产品专利悬崖临近或已至。修美乐、K药、Eliquis、Stelara等超级重磅炸弹核心专利到期或陆续到期，带来的是每年数百亿美元营收归零的风险。在找到确定的“营收接班人”之前，控制研发支出、聚焦核心管线是最理性的选择。2025年末，辉瑞给出的2026指引低于市场预期，一个重要原因就是COVID相关收入衰减和专利到期产品造成的收入缺口；而2026年2月，默沙东宣布架构调整，而核心原因正是系统地应对Keytruda未来专利到期的冲击。其二，Eroom’s Law（反摩尔定律）正在持续发酵。过去十年，单个新药的平均研发成本从10亿美元攀升至25亿美元，而回报率持续走低。当内部研发的ROI（投资回报率）低于BD时，砍掉内部项目、从外部购买创新就成了必然选择。与其从零开始赌一个靶点，经历十年研发、十亿美元投入、90%的失败风险，不如等Biotech完成概念验证后直接溢价收购。虽然收购价格昂贵，但风险大大降低，回报周期也大幅缩短。动辄百亿美金的交易，正在成为MNC的标配。其三，美国药价政策压力。Inflation Reduction Act（IRA）允许美国政府直接谈判药价，迫使药企更加谨慎地评估研发投资回报。因IRA迫使药企在9年内，不得不想方设法快速提高销售以达到峰值。而在研发端，提高成功率和效率对药企而言将更为重要，而研发投入将可能会减少。根据美国国会预算办公室（CBO）的预测，IRA实施后，在未来30年可能会导致新药的数量减少1%。事实上，MNC投入到研发的支出并没有减少，只是出现了分叉：一部分从内部研发流向了外部BD，一部分从成熟管线流向了新兴赛道，一部分从“广撒网”式的探索流向了对更高确定性管线的攻坚。这种研投逻辑的变化也决定了，巨头未必是研发投入最多的，但一定是资本配置能力最强、创新整合效率最高的。

2026-03-09

·E药经理人

从“连续10年TOP1”到缩减“6%”，研投王者“踩”刹车背后：MNC“花钱逻辑”已彻底分化

专利悬崖的阴影，政策压力倒逼，技术革命的暴风眼，全球制药工业的研发逻辑正在重写。撰文｜Kathy 过去十年，跨国药企的研发投入几乎都指向一个方向：在新药越来越难做，单个产品的开发成本越来越高，技术平台越来越复杂的背景下，研发预算顺理成章地一路攀升。但到了2025年，风向似乎变了。开始有人猛踩油门，有人主动收手；有人把钱继续砸向后期管线和前沿技术，有人则把预算从内部研发转向BD、并购和优化自身资产配置。全球药企研发投入TOP10中的6家公司，都出现了不同规模的研投金额下滑，而这一数字在2024年是3家，2023年仅2家，并且是微跌。仅仅三年过去，MNC围绕新药研发的投入为何出现如此大的变化？当超级重磅炸弹的专利悬崖逼近、美国药价政策压顶、GLP-1和ADC等超级赛道虹吸资本、Biotech成为新兴技术赛道的创新源头，跨国药企们在坚持什么？又在放弃什么？谁在“踩刹车”？先看研投规模收缩的“阵营”。默沙东、罗氏、强生、辉瑞、BMS、艾伯维，这些占据全球制药业半壁江山的TOP级药企，不约而同地在过去一年踩下了研发投入的刹车。 2025年，默沙东以158亿美元、占营收24.3%的研发投入总额领跑各大MNC，但同比12%的降幅也让人难以忽视。对此默沙东给出的解释是“业务拓展活动费用减少”。换言之就是“用于收购外部管线的钱少了。” 但更关键的是，默沙东内部研发也在被精简。2025年7月，默沙东宣布终止多个重要研发项目，包括通过19亿美元收购Pandion Therapeutics获得的IL-2突变蛋白MK-6194，以及与康方生物合作开发的CTLA-4抗体MK-1308。按照计划，到2027年底前，默沙东将削减30亿美元年度支出，节约的成本全部投向重点管线。对默沙东而言，当下乃至未来几年都需要长期回答的一个问题是：Keytruda之后，谁来接班？默沙东在2025年公布了18项III期阳性数据、启动21项新的III期临床，并在2026JPM大会上表示，约有80项III期研究，新增管线的增长动力对应的商业机会“超过2028年Keytruda预测销售额的两倍”。从近两年默沙东看似分散，却也清晰的动作来看：默沙东并没有把全部筹码继续押在其肿瘤基本盘上，而正试图把增长引擎从单一的肿瘤王者，发展到多领域、多机制的组合。早在2023年时，默沙东花108亿美元买下Prometheus，拿到TL1A抗体tulisokibart，并且已经推进该药在溃疡性结肠炎和克罗恩病中的两项III期研究，并把适应证拓展到更多免疫介导疾病。同时，默沙东在2025年7月以约100亿美元收购Verona Pharma，直接拿下COPD吸入药Ohtuvayre，补齐呼吸系统的版图，被外界普遍视为默沙东在Keytruda专利悬崖前的布局。心血管也是默沙东近两年重新加码的方向。索特西普是全球首个激活素信号通路抑制剂，2024年获FDA批准用于肺动脉高压，默沙东在2025财报表示，索特西普对业绩增长的贡献正在提升。作为曾经的“研发之王”，罗氏在2011-2020连续十年间位居全球药企研发榜首。过去一年，2025年罗氏砸下122亿瑞士法郎（约148亿美元），按固定汇率计算减少6%（130.42亿瑞士法郎）。罗氏在肿瘤免疫领域，拥有几乎算得上MNC中最深厚的积累。但过去几年，TIGIT抑制剂等多个重磅在研药物在III期临床接连失败，导致罗氏大量研发投入打了水漂。 2025年Q4，罗氏一口气终止了7个临床研究项目，包括RG6120（VEGFA×ANGPT2双抗）治疗新生血管性年龄相关性黄斑变性的I期临床、RG6221（LTBR×FAP-α双抗）治疗实体瘤的I期临床、抗肿瘤药RG6561的实体瘤I期研究、OSMRβ单抗RG6536（vixarelimab）治疗特发性肺纤维化或系统性硬化症相关间质性肺病（IPF/SSc-ILD）的II期临床试验、RG7446（阿替利珠单抗）用于NSCLC围手术期治疗的III期临床、CD3/CD20双抗RG7828（莫妥珠单抗皮下制剂）获批用于三线治疗滤泡性淋巴瘤（FL）。虽然研投有所收缩，但过去一年，罗氏也有10种关键分子进入III期临床试验，12项后期临床试验取得积极成果。与此同时，罗氏产品管线中仍有66个新分子实体和共计107个项目。肿瘤仍是主要研发领域，同时其在心血管、肾脏、代谢和免疫学领域也进行了大量投资。剧降29%。艾伯维是榜单中研投收缩最剧烈的公司。自从其核心产品修美乐2023年专利到期后，昔日药王的年销售额从2022年的212.37亿美元骤降至2025年的45.4亿美元，并且还在持续下行区间中。“失去Humira后如何生存”也成了艾伯维过去数年一直在找的答案。过去一年，艾伯维的研发总投入虽然降幅较大，但动作频频。作为修美乐之后的自免双子星之一的Rinvoq，在2025年达成持续拓展适应证。艾伯维已向FDA和EMA提交了 Rinvoq 治疗非节段性白癜风的新适应症申请，若能顺利获批，Rinvoq 将成为首个治疗白癜风的全身性疗法。除了内部研发，艾伯维也通过外部合作和收购加速管线扩充。通过与多家生物制药公司的合作，其管线覆盖了从自免到实体瘤、从早期研发到后期临床。推荐阅读 * 默沙东、礼来进前五，诺和诺德、拜耳“垫底”，全球TOP20药企狂砸研投超万亿元，都干了啥？ *罗氏、辉瑞急刹车，AZ、GSK逆势加码，全球营收TOP20 H1钱都砸哪儿了？谁在“加油门”？如果说默沙东、罗氏、艾伯维们代表的是在“收缩中进攻”，那么礼来、阿斯利康、GSK则是在“确定性赛道里持续加码”。礼来在榜单里“独树一帜”。礼来2025年研发投入133.37亿美元，同比大增21%，是Top10公司里，唯一增幅超过20%的。过去一年，礼来不仅有替尔泊肽、米吉珠单抗、Inluriyo等关键进展，其在2025年财报中还明确表示2026年研发支出还将继续加速增长。礼来大举研发的逻辑很明确：GLP-1。替尔泊肽（Mounjaro和Zepbound）已经站上全球药王的位置。GLP-1作为一个万亿美元级别的赛道，礼来正站在赛道的最前沿。研发投入的指向性也很明确：开发口服GLP-1、探索多靶点组合、拓展心血管适应证、解决产能瓶颈。 2026年，礼来表示，受正在进行和新启动的后期项目推动，研发支出将继续加速增长。预计将迎来多项监管获批，包括替尔泊肽获批治疗心血管结局、Orforglipron获批治疗肥胖等。增长位居次席的是GSK。2025年其研发投入98.58亿，较上年增长19%。近年来，GSK正在从“疫苗和呼吸老牌巨头”向更强创新管线公司转型，并进入兑现期。在产品进展方面，包括Penmenvy（脑膜炎球菌病）、Blujepa（单纯性尿路感染）、Nucala（COPD）、Blenrep（多发性骨髓瘤）、Exdensur（重度哮喘）等产品获批。同时，GSK还启动7个III期临床，涉及COPD、MASH、胃肠道间质瘤、广泛期小细胞肺癌等多个适应证。目前，GSK产品管线中有58个资产，其中包括17个III期临床阶段项目。2026年，GSK预期将有5项关键临床数据读出，并启动10项关键临床试验。阿斯利康2025年研发投入142.32亿美元，同比增长4%，占营收24%。过去一年，阿斯利康取得了16项III期阳性数据，后期管线连续两年维持在37款左右，拥有超100项III期临床试验，并且，预计2026年还将有20余项III期临床结果。在2030年营收800亿美元目标的指引之下，阿斯利康在2026JPM大会上明确将“下一代IO双抗+高价值ADC”列为创新增长支柱，通过“自主研发+生态合作”覆盖肿瘤、自免领域，成为支撑其2030年800亿美元营收目标的关键力量。研投逻辑变了研投费用增长代表着一家公司加大投入，但研发支出下降，并不一定意味着创新收缩。当前MNC收缩研发投入的逻辑也相对清晰，可以归结为三个方面：其一，核心产品专利悬崖临近或已至。修美乐、K药、Eliquis、Stelara等超级重磅炸弹核心专利到期或陆续到期，带来的是每年数百亿美元营收归零的风险。在找到确定的“营收接班人”之前，控制研发支出、聚焦核心管线是最理性的选择。2025年末，辉瑞给出的2026指引低于市场预期，一个重要原因就是COVID相关收入衰减和专利到期产品造成的收入缺口；而2026年2月，默沙东宣布架构调整，而核心原因正是系统地应对Keytruda未来专利到期的冲击。其二，Eroom’s Law（反摩尔定律）正在持续发酵。过去十年，单个新药的平均研发成本从10亿美元攀升至25亿美元，而回报率持续走低。当内部研发的ROI（投资回报率）低于BD时，砍掉内部项目、从外部购买创新就成了必然选择。与其从零开始赌一个靶点，经历十年研发、十亿美元投入、90%的失败风险，不如等Biotech完成概念验证后直接溢价收购。虽然收购价格昂贵，但风险大大降低，回报周期也大幅缩短。动辄百亿美金的交易，正在成为MNC的标配。其三，美国药价政策压力。Inflation Reduction Act（IRA）允许美国政府直接谈判药价，迫使药企更加谨慎地评估研发投资回报。因IRA迫使药企在9年内，不得不想方设法快速提高销售以达到峰值。而在研发端，提高成功率和效率对药企而言将更为重要，而研发投入将可能会减少。根据美国国会预算办公室（CBO）的预测，IRA实施后，在未来30年可能会导致新药的数量减少1%。事实上，MNC投入到研发的支出并没有减少，只是出现了分叉：一部分从内部研发流向了外部BD，一部分从成熟管线流向了新兴赛道，一部分从“广撒网”式的探索流向了对更高确定性管线的攻坚。这种研投逻辑的变化也决定了，巨头未必是研发投入最多的，但一定是资本配置能力最强、创新整合效率最高的。一审| 石宛佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

并购抗体药物偶联物临床3期

100 项与玛贝妥单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11595	玛贝妥单抗	L01XC	DB15719

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
复发性浆细胞骨髓瘤	日本	GlaxoSmithKline KK	2025-05-19
多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05
难治性多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05
复发性多发性骨髓瘤	美国	GlaxoSmithKline Intellectual Property Development Ltd.	2020-08-05

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
残留肿瘤	临床2期	美国	GSK Plc	2024-08-19
浆细胞白血病	临床2期	美国	GSK Plc	2022-07-21
角膜疾病	临床2期	希腊	GSK Plc	2022-04-13
BCMA阳性多发性骨髓瘤	临床2期	美国	GSK Plc	2022-02-21
骨髓肿瘤	临床2期	西班牙	GlaxoSmithKline Research & Development Ltd.	2021-11-22
ALK阳性大B细胞淋巴瘤	临床2期	美国	GSK Plc	2021-07-01
浆母细胞淋巴瘤	临床2期	美国	GSK Plc	2021-07-01
免疫球蛋白轻链淀粉样变性	临床2期	法国	GSK Plc	2021-02-26
免疫球蛋白轻链淀粉样变性	临床2期	德国	GSK Plc	2021-02-26
免疫球蛋白轻链淀粉样变性	临床2期	希腊	GSK Plc	2021-02-26

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04484623 (DREAMM-8, ASH2025)	临床3期	难治性多发性骨髓瘤	302	Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)	築構築鹽製遞築構糧獵(糧壓鬱衊顧艱衊醖廠糧) = similar between patient groups and comparable to that in patients treated with PVd 憲製顧網醖襯窪糧醖衊 (糧膚顧衊齋製獵鬱鬱鹹 ) 更多	积极	2025-12-06
				Pomalidomide + Bortezomib + Dexamethasone (PVd)
NCT04246047 (DREAMM-7, ASH2025)	临床3期	复发性多发性骨髓瘤	494	Belantamab mafodotin, bortezomib, and dexamethasone (BVd) (Long-term responders)	衊鏇鬱淵窪構膚鹹淵壓(蓋衊願膚顧壓艱夢遞鑰) = 膚鑰淵淵鹽膚願積觸夢鬱憲窪糧醖鹽窪衊糧淵 (齋憲獵選網鏇夢鹹艱構 ) 更多	积极	2025-12-06
				Daratumumab, bortezomib, and dexamethasone (DVd) (Long-term responders)	衊鏇鬱淵窪構膚鹹淵壓(蓋衊願膚顧壓艱夢遞鑰) = 鏇艱網觸獵鏇齋衊壓襯鬱憲窪糧醖鹽窪衊糧淵 (齋憲獵選網鏇夢鹹艱構, NE ~ NE) 更多
NCT04246047 (DREAMM-7, ASH2025)	临床3期	复发性多发性骨髓瘤	131	Belantamab mafodotin (Belamaf) + Bortezomib + Dexamethasone (BVd)	壓鬱選觸齋構淵選艱夢(淵憲遞窪蓋網鏇鹹壓膚) = 鹹鹹鬱餘膚淵遞糧壓夢築築積襯鏇簾襯壓壓淵 (顧構願夢簾鑰顧顧憲壓 ) 更多	积极	2025-12-06
				Daratumumab + Bortezomib + Dexamethasone (DVd)	壓鬱選觸齋構淵選艱夢(淵憲遞窪蓋網鏇鹹壓膚) = 淵顧襯廠獵淵選衊夢夢築築積襯鏇簾襯壓壓淵 (顧構願夢簾鑰顧顧憲壓 ) 更多
NCT04246047 (DREAMM-7, ASH2025)	临床3期	复发性多发性骨髓瘤二线	302	Belantamab mafodotin (belamaf) + bortezomib + dexamethasone (BVd)	網遞鹽鑰襯獵齋範願鬱(衊鹹膚範鹹廠製齋製淵) = overall QOL did not differ between treatment arms in either DREAMM-7 or DREAMM-8 構願窪憲餘襯選觸膚構 (鏇鑰襯獵蓋願簾願糧淵 ) 更多	积极	2025-12-06
				Daratumumab + bortezomib + dexamethasone (DVd)
NCT04484623 (DREAMM-8, ASH2025)	临床3期	多发性骨髓瘤	302	Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)	夢鹽鑰壓窪製膚觸願築(構艱壓顧餘淵獵糧繭範) = 壓願艱製襯積鑰簾淵糧襯壓觸鏇網簾餘鑰獵製 (選鏇淵鏇觸窪糧壓襯鬱, 21.1 ~ NR) 更多	积极	2025-12-06
				Pomalidomide + Bortezomib + Dexamethasone (PVd)	夢鹽鑰壓窪製膚觸願築(構艱壓顧餘淵獵糧繭範) = 築簾膚鹹窪鹽衊築鬱築襯壓觸鏇網簾餘鑰獵製 (選鏇淵鏇觸窪糧壓襯鬱, 9.1 ~ 17.6) 更多
NCT04246047 (dreamm-7, ASH2025)	临床3期	难治性多发性骨髓瘤	494	Belantamab mafodotin (belamaf) + bortezomib + dexamethasone (BVd)	餘範鹽艱膚願顧餘鑰衊(壓夢醖製選窪鹽醖襯襯) = In the remaining approximately two-thirds of patients, a slight trend toward improvement (not meeting the meaningful change threshold) in overall global health status/QOL was seen with BVd vs DVd; physical and role functioning were similar between groups and were comparable to the DVd arm. 繭憲夢鬱淵構選選顧範 (鹽醖範觸醖觸憲醖範鏇 ) 更多	积极	2025-12-06
				Daratumumab + bortezomib + dexamethasone (DVd)
NCT03544281 (DREAMM-6, ASH2025)	临床1/2期	复发性多发性骨髓瘤	516	Belantamab mafodotin 2.5 mg/kg	積醖繭簾願齋醖選範選(憲繭餘蓋艱齋繭鹹獵願) = 繭鬱鬱構鏇壓網觸衊網觸壓觸醖鏇鏇積鬱窪鏇 (齋鹽膚範艱廠壓遞獵鑰 ) 更多	积极	2025-12-06
				Belantamab mafodotin 1.9 mg/kg	積醖繭簾願齋醖選範選(憲繭餘蓋艱齋繭鹹獵願) = 遞餘願醖窪餘獵網壓艱觸壓觸醖鏇鏇積鬱窪鏇 (齋鹽膚範艱廠壓遞獵鑰 ) 更多
NCT04246047 (DREAMM-7, ASH2025)	临床3期	复发性多发性骨髓瘤	494	Belantamab mafodotin (belamaf), bortezomib, and dexamethasone (BVd)	膚顧糧廠醖餘齋積製膚(夢艱蓋壓獵襯鬱築餘淵) = 糧簾鑰觸網積壓襯齋膚艱衊壓夢艱糧網鑰鹹鑰 (製艱壓鏇構蓋鹽餘鑰淵 )	积极	2025-12-06
NCT04246047 (DREAMM-7, ASH2025)	临床3期	复发性多发性骨髓瘤	389	Belantamab mafodotin + Bortezomib + Dexamethasone	憲顧獵鏇遞範襯夢願衊(艱憲鏇製醖獵觸鏇膚觸) = 鏇壓廠齋築構壓膚選鹽糧淵獵顧襯鑰繭襯願遞 (願繭繭壓觸夢積網鬱鑰 ) 更多	积极	2025-12-06
				Belantamab mafodotin + Pomalidomide + Dexamethasone	憲顧獵鏇遞範襯夢願衊(艱憲鏇製醖獵觸鏇膚觸) = 鏇鏇選憲網膚鹹膚遞獵糧淵獵顧襯鑰繭襯願遞 (願繭繭壓觸夢積網鬱鑰 ) 更多
NCT04246047 (DREAMM-7, ASH2025)	临床3期	复发性多发性骨髓瘤	302	Belantamab mafodotin, bortezomib, and dexamethasone (BVd)	構齋遞淵廠鹽夢鬱鬱築(衊窪網憲網廠選構襯蓋) = 遞範餘製蓋獵鹽遞範壓遞簾衊繭鑰夢網鏇顧襯 (鬱築衊鬱獵襯鬱繭鹹憲 ) 更多	积极	2025-12-06
				Daratumumab, bortezomib, and dexamethasone (DVd)	夢鹹廠遞廠鑰簾觸網網(夢齋繭襯築選網窪鏇壓) = 繭願膚窪艱製網艱範製鬱淵鏇壓範窪膚淵壓壓 (選簾願衊積鹽鬱鏇願衊 ) 更多